Orsiro 3.0/22/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07640130439115), received between Apr 25, 2019 and Jul 20, 2021 — classified as 1 death, 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS RCA. THE STENT COULD NOT PASS THE LESION AND WAS DEFORMED AT THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196890 ↗
• MalfunctionMar 11, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DESPITE SEVERAL PRE-DILATATIONS, THE LESION COULD NOT BE CROSSED WITH THE DEVICE. A STENT DEFORMATION WAS DETECTED. A GUIDELINER WAS USED DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467150 ↗
• InjuryNov 10, 2020Use of Device Problem; Use of Device Problem

  AN ORSIRO US DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING ATTEMPT TO STENT A PROXIMAL LAD LESION A DISSECTION OCCURRED. A SECOND STENT WAS USED FOR THE DISSECTION AND OVERLAPS WITH THE INITIAL STENT.

  Patient problems: Vascular Dissection

  MAUDE report 10818104 ↗
• MalfunctionSep 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A CALCIFIED LESION IN THE CIRCUMFLEX. THE ORSIRO STENT DISLODGED FROM THE DELIVERY BALLOON INSIDE THE GUIDELINER EXTENSION CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478575 ↗
• MalfunctionFeb 3, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A LESION IN THE RCA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE AND WAS REMOVED. AFTER WITHDRAWAL IT WAS DETECTED THAT THE STENT WAS DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9662438 ↗
• DeathJan 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AFTER PRE-DILATATION OF A MODERATE CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS LAD AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED. THE ORSIRO COULD NOT CROSS THE LESION AND WAS REMOVED. THE LESION WAS DEFLATED AGAIN AND THE SAME DEVICE WAS RE-INSERTED. THE ORSIRO COULD NOT CROSS AGAIN. DURING WITHDRAWAL, THE STENT DISLODGED AND AN ATTEMPT WAS MADE TO RETRIEVE THE STENT WITH A SNARE, BUT UNSUCCESSFUL. THE STENT WAS THEN ADAPTED TO THE VESSEL WALL BY USING DIFFERENT BALLOON CATHETERS. DURING THE FOLLOW-UP WITH THE HOSPITAL WE RECEIVED THE INFORMATION THAT THE PATIENT PASSED AWAY. THE DEATH WAS REPORTED AS NOT DEVICE RELATED.

  Patient problems: Death

  MAUDE report 9639311 ↗
• MalfunctionJan 13, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. DURING WITHDRAWAL THE STENT WAS DISLODGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580538 ↗
• MalfunctionDec 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING REMOVAL OF THE PROTECTOR THE STENT DISLODGED FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9497656 ↗
• MalfunctionDec 16, 2019Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A CALCIFIED LESION IN THE PROXIMAL RCA. WHILE IT WAS ATTEMPTED TO PULL THE STENT OUT OF THE ARTERY AND THROUGH THE GUIDING CATHETER IT WAS NOTICED THAT AT THE PROXIMAL END OF THE ORSIRO STENT, A STENT STRUT HAD BENT UPWARDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475630 ↗
• MalfunctionAug 15, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED PRE-DILATED LESION (99 PERCENT STENOSIS DEGREE) IN TORTUOUS OM. THE DEVICE COULD NOT CROSS THE LESION. DURING WITHDRAWAL THE STENT DISLODGED AND WAS ADAPTED TO THE VESSEL WALL WITH ANOTHER STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8897357 ↗
• MalfunctionApr 25, 2019Material Deformation; Material Deformation

  AN ORSIRO WAS FIRST PLACED IN THE DISTAL PORTION OF THE VESSEL. WHILE TRYING TO PLACE A SECOND ORSIRO IN AN OVERLAPPING MANNER, RESISTANCE WAS EXPERIENCED AND THE DEVICE WAS WITHDRAWN. AFTER REMOVAL THE STENT WAS VISIBLY BENT ON THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8552455 ↗